UPDATE 1-Cell Therapeutics says FDA accepts NDA for cancer drug

Mon Aug 24, 2009 7:52am EDT

* FDA to set action date by Sept 4

* Shares up 7 percent before the bell

Aug 24 (Reuters) - U.S.-Italian drug company Cell Therapeutics Inc (CTIC.O) (CTIC.MI) said U.S. health regulators have accepted and filed for review the company's application seeking marketing approval for its experimental drug to treat a type of cancer that affects the lymphatic system.

The U.S. Food and Drug Administration has designated a standard review for pixantrone as a treatment for relapsed, aggressive non-Hodgkin's lymphoma, the company said.

In November last year, the company said pixantrone met the main goal of a late-stage trial for the same indication.

The FDA will set the action date regarding the review of pixantrone by Sept. 4, the company said.

Shares of the company rose 7 percent to $1.81 in trading before the bell. They closed at $1.69 Friday on Nasdaq.

For the alerts, please double-click [ID:nWNAB2895] (Reporting by Shailesh Kuber in Bangalore; Editing by Deepak Kannan)

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